FDA.reportPublic FDA data

EMHS 1 Hand Sanitizer

Manufacturer
Sayida Group
Effective date
2020-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:13

Label at a glance#

ProductEMHS 1 Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure13 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v.

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, citrus oil, fragrance, glycerin, rosemary oil, triethanolamine, water

Side Panel

SPL UNCLASSIFIED SECTION

Without rinsing. Non-sticky formula. Disinfecting anti-bacterial gel.

DIRECTIONS: Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

WARNINGS: For external use only. Flammable. Keep away from heat or flame. Do not use on children less than 2 months of age or on open skin wounds. Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use if rash or irritation occurs. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Distributed by: Sayida Group LLC

6538 Collins Ave #401

Miami Beach, FL33141

www.emhs1.com

Made In Mexico

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

isopropyl alc. hand sanitizerisopropyl alc. hand sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2285607isopropyl alcohol 75 % Topical GelPSN1
2285607isopropyl alcohol 0.75 ML/ML Topical GelSCD1
2285607isopropyl alcohol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77858-0752-12022-01-28C16284748780-1d6a99b39-3e87-a426-e053-dadaa90af4c2EMHS 1 Hand Sanitizer (1 Gal pump)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77858-0752-1EMHS 1 Hand Sanitizer3.79 L in 1 BOTTLE, PUMPGEL3.791

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77858-0752EMHS 1 HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [SAYIDA GROUP]1Legacy NDC, 1 package rows20200522_a62e8f13-2a93-3b09-e053-2a95a90abb48.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77858-075277858-0752-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
ROSEMARY OIL8LGU7VM393IACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 1342809Y72KV36IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a62e8d66-ce6a-9eb9-e053-2995a90afb16a62e8f13-2a93-3b09-e053-2a95a90abb482020-05-21WarningsExact identifier
spl id: a62e8d66-ce6a-9eb9-e053-2995a90afb16
spl set id: a62e8f13-2a93-3b09-e053-2a95a90abb48

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.